Influence of Adiponutrin in Chronic Liver Disease

This study has been completed.

Sponsor:

Information provided by:

Erasme University Hospital

ClinicalTrials.gov Identifier:

NCT01122797

First received: May 11, 2010

Last updated: NA

Last verified: December 2002

History: No changes posted

Tracking Information
First Received Date ^ICMJE	May 11, 2010
Last Updated Date	May 11, 2010
Start Date ^ICMJE	January 2003
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 11, 2010)	Assessment of fibrosis and steatosis by liver biopsy in alcoholic liver disease patients. After liver histology assessment for liver liver dammage a potential correlation of fibrosis and steatosis was studied with rs738409 PNPLA3 polymorphism
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Influence of Adiponutrin in Chronic Liver Disease
Official Title ^ICMJE	Study of Metabolism Influence in Human Alcoholic Liver Disease
Brief Summary	Increasing evidence attests the influence of multiple metabolic genetic risk factors in the progression of alcoholic liver disease. Deleterious pathways involved in metabolism such as lipid peroxidation and cytokines have been implicated in promoting inflammation leading to fibrosis increase and liver injury progression. The aim of this study was to assess the role of rs738409 single nucleotide polymorphism in the PNPLA3 gene in alcoholic liver disease patients.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: DNA extraction from whole blood sample. Piece of liver tissue in the alcoholic liver disease group.
Sampling Method	Probability Sample
Study Population	Consecutive patients undergoing transjugular liver biopsy for alcoholic liver disease will be included in the study to determine the potential correlation between rs738409 PNPLA3 polymorphism and/or PNPLA3 mRNA expression.
Condition ^ICMJE	Alcoholic Liver Disease
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Alcoholic liver disease Alcoholic liver disease patients undergoing a transjugular liver biopsy in our institution Controls Healthy controls patients recruited from the Occupational Medicine Department during a routine physical examination.
Publications *	Tian C, Stokowski RP, Kershenobich D, Ballinger DG, Hinds DA. Variant in PNPLA3 is associated with alcoholic liver disease. Nat Genet. 2010 Jan;42(1):21-3. Epub 2009 Nov 29. Romeo S, Kozlitina J, Xing C, Pertsemlidis A, Cox D, Pennacchio LA, Boerwinkle E, Cohen JC, Hobbs HH. Genetic variation in PNPLA3 confers susceptibility to nonalcoholic fatty liver disease. Nat Genet. 2008 Dec;40(12):1461-5. Epub 2008 Sep 25. Yuan X, Waterworth D, Perry JR, Lim N, Song K, Chambers JC, Zhang W, Vollenweider P, Stirnadel H, Johnson T, Bergmann S, Beckmann ND, Li Y, Ferrucci L, Melzer D, Hernandez D, Singleton A, Scott J, Elliott P, Waeber G, Cardon L, Frayling TM, Kooner JS, Mooser V. Population-based genome-wide association studies reveal six loci influencing plasma levels of liver enzymes. Am J Hum Genet. 2008 Oct;83(4):520-8. Huang Y, He S, Li JZ, Seo YK, Osborne TF, Cohen JC, Hobbs HH. A feed-forward loop amplifies nutritional regulation of PNPLA3. Proc Natl Acad Sci U S A. 2010 Apr 27;107(17):7892-7. Epub 2010 Apr 12. He S, McPhaul C, Li JZ, Garuti R, Kinch L, Grishin NV, Cohen JC, Hobbs HH. A sequence variation (I148M) in PNPLA3 associated with nonalcoholic fatty liver disease disrupts triglyceride hydrolysis. J Biol Chem. 2010 Feb 26;285(9):6706-15. Epub 2009 Dec 23. Kotronen A, Peltonen M, Hakkarainen A, Sevastianova K, Bergholm R, Johansson LM, Lundbom N, Rissanen A, Ridderstråle M, Groop L, Orho-Melander M, Yki-Järvinen H. Prediction of non-alcoholic fatty liver disease and liver fat using metabolic and genetic factors. Gastroenterology. 2009 Sep;137(3):865-72. Epub 2009 Jun 12. Kotronen A, Johansson LE, Johansson LM, Roos C, Westerbacka J, Hamsten A, Bergholm R, Arkkila P, Arola J, Kiviluoto T, Fisher RM, Ehrenborg E, Orho-Melander M, Ridderstråle M, Groop L, Yki-Järvinen H. A common variant in PNPLA3, which encodes adiponutrin, is associated with liver fat content in humans. Diabetologia. 2009 Jun;52(6):1056-60. Epub 2009 Feb 18. Valenti L, Al-Serri A, Daly AK, Galmozzi E, Rametta R, Dongiovanni P, Nobili V, Mozzi E, Roviaro G, Vanni E, Bugianesi E, Maggioni M, Fracanzani AL, Fargion S, Day CP. Homozygosity for the patatin-like phospholipase-3/adiponutrin I148M polymorphism influences liver fibrosis in patients with nonalcoholic fatty liver disease. Hepatology. 2010 Apr;51(4):1209-17. Trépo E, Gustot T, Degré D, Lemmers A, Verset L, Demetter P, Ouziel R, Quertinmont E, Vercruysse V, Amininejad L, Deltenre P, Le Moine O, Devière J, Franchimont D, Moreno C. Common polymorphism in the PNPLA3/adiponutrin gene confers higher risk of cirrhosis and liver damage in alcoholic liver disease. J Hepatol. 2011 Oct;55(4):906-12. Epub 2011 Feb 18.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	658
Completion Date	March 2010
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	ALD patients: Inclusion Criteria: Excess alcohol intake Abnormal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) or a suspicion of cirrhosis related to ALD Caucasian ethnicity Exclusion Criteria: Presence of any other chronic liver disease Co-infection with human immunodeficiency virus Controls: Inclusion Criteria: Caucasian ethnicity Exclusion Criteria: Presence of a disease
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Belgium

Administrative Information
NCT Number ^ICMJE	NCT01122797
Other Study ID Numbers ^ICMJE	ET-PNPLA3
Has Data Monitoring Committee	Yes
Responsible Party	Eric Trépo, MD, Erasme University Hospital (Olivier Le Moine, MD, PhD)
Study Sponsor ^ICMJE	Erasme University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Erasme University Hospital
Verification Date	December 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top